Location: New York, NY
Reports to: Director, Clinical Operations
Clinical Research Associate: In-House
Axsome Therapeutics is currently searching for Clinical Research Associates (CRAs) to support our exciting clinical development programs. We are a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a balanced portfolio of clinical development stage as well as research stage product candidates. Axsome is located in New York City, New York.
The ideal candidate is office-based, consideration will be given to a remote position for qualified candidates.
The CRA is responsible for supporting the organization to successfully develop and implement clinical trials across its product candidate portfolio and development pipeline. For each assigned study, the CRA is responsible for: conducting site evaluation visits, managing the site startup process, leading site initiation activities, building site relationships, conducting remote data review and on-site monitoring, ensuring proper site closeout and database lock. This position plays a key role to ensure the successful execution of clinical studies in accordance with SOPs, FDA and other regulatory authority regulations, GCP, and ICH guidelines.
- Possess detailed knowledge of the study protocol, disease state, and ICH-GCP regulations.
- Leads site evaluation through site initiation activities, including collection of required regulatory documentation.
- Generates and completes appropriate documentation regarding site management, visits, monitoring visit findings and corresponding action plans.
- Builds relationships with study site and acts as key liaison during study.
- Conducts remote reviews of clinical data.
- Periodic on-site monitoring to ensure subject safety, protocol compliance, and adherence to ICH-GCP.
- Conduct close-out visits to ensure proper study closeout at each assigned study site.
- Responsible for ensuring site follows appropriate drug storage and accountability procedures.
- Participates in team CRA meetings.
- Provides ongoing QC of the eTMF and reconciliation of site files with TMF.
- Conduct training sessions for site personnel on study protocol requirements, data collection systems, and GCP, as needed.
- All other duties as required.
- BS degree in a biological or physical life science or a Registered Nurse preferred.
- Prior experience as a CRA, highly preferred (CRO or sponsor). CRA level will depend on prior experience level.
- Demonstrates strong knowledge of GCP, FDA regulations, and ICH guidelines.
- Computer skills including: Microsoft Office Suite, CTMS platforms, and eCRF platforms.
- Excellent written and verbal communication skills.
- Able to comfortably interact with company personnel, study vendors, and investigational sites.
- Must have strong organization skills, be self-motivated, and function independently.
- Willingness to travel (up to 80%).
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Excellent team player; willingness and ability to fill functional gaps in a small but growing organization.